PharmaEngine, Inc. announced first patient dosed in Phase I trial of PEP07 for solid tumor cancers. PEP07 Phase 1 clinical trial for solid tumors received approval from TFDA in September 2023. PEP07 is a checkpoint kinase 1 (CHK1) inhibitor featuring high kinase selectivity, high potency and brain penetrating which targets the DNA Damage Response (DDR) pathway.

PEP07 has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical model. Currently, PharmaEngine is conducting a PEP07 Phase 1 clinical trial for solid tumor cancers in Taiwan and Company are announcing that the first patient has been dosed. Title: PEP07-102: Participants and Investigator Sites: Approximately a total of 30 participants in Taiwan; Primary Objectives: Evaluate the safety and identify the Recommended Phase 2 Dose (RP2D) of PEP07 for solid tumor cancer patients; Study Phase: 1; Protocol Number: PEP07-102; Clinical Study Design: Open label dose finding study.

New drug name or code: PEP07 Indication: PEP07 is a checkpoint kinase 1 (CHK1) inhibitor featuring high kinase selectivity, high potency and brain penetrating which targets the DNA Damage Response (DDR) pathway. Planned development stages: Phase 1 to 3 clinical studies, then apply for NDA. Current development stage: Application.

submission/approval/disapproval/each of clinical trials (include interim analysis): Approval Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: None After obtaining official approval or the results of statistically significant sense, the future strategy: PEP07 is a CHK1 inhibitor with features such as high kinase selectivity, high potency and brain penetrating. The main function is to trigger replication catastrophe which leads to apoptosis in the cancer cell during DNA damage. PEP07 has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical model.

Currently, PharmaEngine has been conducting Phase 1 clinical trials for hematologic and solid tumor cancers. Accumulated investment expenditure incurred:Due to possible future involvement of international cooperation negotiations or product marketing strategies, to protect the rights and interests of investors, we will not disclose the investment expenditure at the time being. Upcoming development plan: Estimated date of completion: It is expected to be completed in about two years for the clinical study.

Estimated responsibilities: All expenditures are solely funded by PharmaEngine, Inc. Market situation:Per the latest data provided by World Health Organization's GLOCAN database, worldwide, in 2022, there was an estimated 19.98 million new cancer cases and around 9.74 million cancer deaths. New drug development requires long process, vast investments, and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct a thorough evaluation.